Side Effects After Direct-acting Antiviral Treatment (EFINO-C)

November 15, 2017 updated by: Hospices Civils de Lyon

Side Effects After Direct-acting Antiviral Treatment in Patients With Chronic Hepatitis C. The EFINO-C Study.

The objective of this study was to assess the incidence of side effects after direct-acting antiviral therapy in patients with chronic hepatitis C virus infection.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Direct-acting antiviral (DAA)-based treatments are today very effective The objective of this study was to assess the incidence of side effects after DAA therapy in patients with chronic hepatitis C virus infection.

Study Type

Observational

Enrollment (Actual)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69004
        • Croix-Rousse hospital, Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic hepatitis C treated with direct-acting antiviral treatment

Description

Inclusion Criteria:

  • 18 years of age or older
  • Hepatitis C virus infection
  • Treatment by direct-acting antiviral combination

Exclusion Criteria:

  • HIV coinfection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of side effects
Time Frame: Within treatment duration, i.e. 8, 12 or 24 weeks after treatment initiation
Incidence of side effects occurring during treatment duration. Treatment duration may be of 8 weeks, 12 weeks or 24 weeks depending on treatment combination.
Within treatment duration, i.e. 8, 12 or 24 weeks after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2016

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 20, 2017

Study Record Updates

Last Update Posted (Actual)

November 20, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRC_GHN_2017_004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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